Fenestrated pedicle nail

ABSTRACT

Embodiments are directed to spinal treatments and, more particularly, to a fenestrated pedicle nail, wherein the pedicle nail performs as an anchored system for pedicle instrument constructs that prevents fracturing from over-compressing of bone of poor quality. Embodiments include a pedicle nail comprising a shank and a nail head. The shank may comprise a proximal end and a distal bone engagement end. The nail head may be disposable on the proximal end of the shank, wherein the nail head may threadably engage the proximal end thereof. The nail head may have external bone threads.

CROSS-REFERENCE TO RELATED APPLICATIONS)

This application is a continuation of U.S. Pat. Application No.16/452,645, filed on Jun. 26, 2019 (published as U.S. Pat. Pub. No.2020-0405362), which is incorporated herein by reference in its entiretyfor all purposes.

BACKGROUND

Many types of spinal irregularities can cause pain, limit range ofmotion, or injure the nervous system within the spinal column. Theseirregularities can result from, without limitation, trauma, tumor, discdegeneration, and disease. Often, these irregularities may be treated byimmobilizing a portion of the spine. This treatment typically mayinvolve affixing a plurality of screws and/or hooks to one or morevertebrae and connecting the screws or hooks to an elongated rod thatgenerally extends in the direction of the spine.

Treatment for these spinal irregularities often involves using a systemof pedicle screws and rods to attain stability between spinal segments.Instability in the spine can create stress and strain on neurologicalelements, such as the spinal cord and nerve roots. In order to correctthis, implants of certain stiffness can be implanted to restore thecorrect alignment and portion of the vertebral bodies. In many cases, ananchoring member such as a pedicle screw along with a vertical solidmember may help restore spinal elements to a pain free situation, or atleast may help reduce pain or prevent further injury to the spine.

A pedicle screw system is sometimes used as an adjunct to spinal fusionsurgery, thereby providing a means of gripping a spinal segment. Aconventional pedicle screw system may comprise a pedicle screw and areceiving device. The pedicle screw may include an externally threadedstem and a head portion. The rod-receiving device may couple to the headportion of the pedicle screw and can receive a rod, commonly referred toas a distraction rod. Two such systems may be inserted into respectivevertebrae and adjusted to distract and/or stabilize a spinal column, forinstance during an operation to correct a herniated disk. The pediclescrew does not, by itself, fixate the spinal segment, but instead mayoperate as an anchor point to receive the rod-receiving device, which inturn receives the rod. One goal of such a system may be to substantiallyreduce and/or prevent relative motion between the spinal segments thatare being fused.

Although the pedicle screw minimizes relative motion between the spinalsegments, the pedicle screw is still subject to windshield-wiperloosening, which can potentially result in pull out of the pediclescrew. Accordingly, there exists a need to further decrease axialmotion.

SUMMARY

A first exemplary embodiment provides a pedicle nail that may comprise ashank and a nail head. The shank may comprise a proximal end and adistal bone engagement end. The nail head may be disposable on theproximal end of the shank, wherein the nail head may threadably engagethe proximal end, and wherein the nail head can have external bonethreads.

A second exemplary embodiment provides a pedicle nail system that maycomprise a pedicle nail and a tulip. The pedicle nail may comprise ashank, wherein the shank may comprise a proximal end and a distal boneengagement end, wherein the proximal end may comprise mounting threadsattached thereto. The tulip may comprise a proximal end and a distal end

A third exemplary embodiment provides a pedicle nail system that maycomprise a pedicle nail, a tulip, and a driver. The pedicle nail maycomprise a shank, wherein the shank may comprise a proximal end and adistal bone engagement end, wherein the proximal end may comprisemounting threads attached thereto. The tulip may comprise a proximal endand a distal end, wherein the tulip may be configured to be mounted onthe pedicle nail. The driver may comprise a proximal end and a distalend; wherein the distal end of the driver is removably connected to theproximal end of the insertion tool assembly.

Further areas of applicability of the present invention will becomeapparent from the detailed description provided hereinafter. It shouldbe understood that the detailed description and the specific examples,while indicating the preferred or exemplary embodiments of theinvention, are intended for purposes of illustration only and are notintended to limit the scope of the invention.

BRIEF DESCRIPTION OF THE DRAWINGS

These drawings illustrate certain aspects of some examples of thepresent disclosure, and should not be used to limit or define thedisclosure, wherein:

FIGS. 1A and 1B illustrate an embodiment of a fenestrated pedicle nailwith the nail head connected thereto;

FIG. 2 illustrates an embodiment of a fenestrated pedicle nail withoutthe nail head connected thereto;

FIGS. 3A, 3B, and 3C illustrate an embodiment of a nail head;

FIGS. 4A and 4B illustrate embodiments of a fenestrated pedicle nailwith a tulip connected thereto;

FIGS. 5A, 5B, and 5C illustrate an embodiment of a monoaxial tulip;

FIGS. 6A, 6B, and 6C illustrate an embodiment of a polyaxial tulip;

FIG. 7 illustrates an embodiment of a curved awl; and

FIGS. 8A, 8B, 8C and 8D illustrate an embodiment of a monoaxialinsertion tool assembly comprising a threaded shaft locking assembly fora monoaxial tulip.

FIGS. 9A and 9B illustrate a driver coupled with a pedicle nail system.

FIGS. 10A and 10B illustrate an embodiment of a curved awl creating apathway for insertion of a pedicle nail.

FIGS. 11A and 11B illustrate an embodiment of a pedicle nail system,including a driver, with a tamping device driving the pedicle nail intoa cortical bone.

FIGS. 12A and 12B illustrate a polyaxial tulip insertion procedure withan embodiment of the nail head of a pedicle nail system being threadedinto the cortical bone with an insertion tool assembly.

FIGS. 13A, 13B, and 13C illustrate a monoaxial tulip insertion procedurewith an embodiment of the nail head of a pedicle nail system beingthreaded into the cortical bone with an insertion tool assembly.

FIGS. 14A and 14B illustrate the final placement of tulips in relationto the cortical bone.

DETAILED DESCRIPTION

Embodiments are directed to spinal treatments and, more particularly, toa pedicle nail, wherein the pedicle nail performs as an anchored systemfor pedicle instrument constructs that prevents fracturing fromover-compressing of bone of poor quality. Embodiments of the pediclenail may be used in a wide variety of spinal treatments for treatment ofspinal irregularities, where the pedicle nail can increase stability ofthe bone/nail interface in the cancellous region of the vertebral body;reduce pull-out of the nail from the windshield-wiper effect; minimizethe diameter of the nail or other pedicle instrument needed in arevision procedure; and reduce the risk of fracturing fromover-compression.

Embodiments of the pedicle nail can be implanted inside a cancellousregion of the vertebral body, attached to a nail head implanted into thecortical bone. The pedicle nail can be curved with a curvature angle θ.Hence, although a bone screw may be subject to windshield-wiperloosening, the geometry of the curved pedicle nail can change theinsertion vector, thereby reducing the axial motion. In someembodiments, the difference between the pitch of the mounting thread ofthe pedicle nail and the bone screw thread of the nail head can decreasethe chance of over-compression because the nail can be pulled toward thenail head, traveling through a cavity that was previously created usinga curved awl.

In some embodiments, a medical professional (e.g., a surgeon) may firstprepare for the area to be treated by creating an incision in apatient’s back and adjusting the lower back muscles to access thedesired area. Some embodiments may use the curved awl to create apathway for insertion of the pedicle nail. Embodiments may then includetamping down the pedicle nail, for example, with a tamping or hammeringtool, until the nail head contacts the cortical bone. In at least oneembodiment, the nail head, having external bone threads thereupon, maybe threaded into the cortical bone, then a polyaxial tulip may beassembled by threadable connection to the proximal end of the nail head.Alternatively, the nail head may be removed after tamping for threadableattachment of a monoaxial tulip to the proximal end of the pedicle nail.More specifically, for example, a threaded shaft locking assembly,having an outer shaft and an inner shaft, may be retracted to allow theouter shaft to be threaded into a monoaxial tulip and seated therein.The monoaxial tulip can then be threaded into the cortical bone.

FIGS. 1A, and 1B illustrate a pedicle nail 100 in accordance withexample embodiments. In the illustrated embodiment, the pedicle nail 100comprises a shank 102 having a proximal end 104 and a distal boneengagement end 106. As illustrated, the distal bone engagement end 106may include bone threads or notches 105 thereabout. Embodiments of thepedicle nail 100 may further include a nail head 108 disposable on theproximal end 104 of the shank 102. As illustrated, the nail head 108 maythreadingly engage the proximal end 104 of the shank 102. Embodiments ofthe nail head 108 may also include external bone threads 110. The nailhead 108 will be described in more detail below with respect to FIGS.3A, 3B, and 3C.

In the illustrated embodiment, the pedicle nail 100 has fenestratedperforations 112 positioned about the longitudinal axis of the shank102. Accordingly, embodiments of the pedicle nail 100 may be referred as“fenestrated.” However, it should be understood that the fenestratedperforations 112 are optional and embodiments of the pedicle nail 100may not include the fenestrated perforations 112. The shank 102 may alsoinclude at least two protrusions configured along the longitudinal axis,wherein the protrusions 113 form channels 115 along the longitudinalaxis of the shaft 102. The protrusions 113 may have an exposed verticaledge, wherein the vertical edge may have at least two notches 114therein, wherein the notches 114 may be in vertical alignment with oneanother.

As illustrated, the shank 102 can be a curved shank, having a curvatureangle θ. The shank 102 can have any suitable curvature angle θ. Thosewith ordinary skill in the art will appreciate the curved shank 102, inthat the curvature angle θ may allow for rotational movement or angularadjustment of the pedicle nail 100 in connection with bone structures.Moreover, the curved shank 102 may have several additional features,including, but not limited to, thread pitch, shank diameter to threaddiameter, overall shank shape, and the like, depending, for example, onthe particular application.

Specifically referring to FIG. 2 , an embodiment of the pedicle nail 100is illustrated without the nail head 108 attached thereto. As shown inFIG. 2 , the shank 102 includes mounting threads 216 disposed about theproximal end 104. With additional reference to FIGS. 1A and 1B, themounting threads 216 of the shank 102 can be threadingly connected tothe nail head 108. In at least one embodiment, the pedicle nail 100 caninclude differences in pitch between the mounting threads 216 and thenail head bone threads 110 of the nail head 108. Pitch is the distancebetween threads and may be expressed in millimeters. For example, apitch of 1.25 indicates a distance between threads of 1.25 millimeters.In some embodiments, the bone threads 110 may have a pitch that isgreater than a pitch of the mounting threads 216. For example, the pitchof the bone threads 110 may be greater than the pitch of the mountingthreads 216 by about 0.1 millimeters, 0.2 millimeters, 0.3 millimeters,or greater. The differences in pitch can pull the pedicle nail 100toward the nail head 108 during implantation. The pedicle nail 100 cantravel through a cavity previously created by a medical professional,(e.g., a surgeon) using instruments such as a curved awl 600 (e.g.,shown on FIG. 6 ); thereby helping to prevent over-compression.

In one embodiment (not shown), the pedicle nail 100 can be cannulated,which means a channel can extend axially through the entire length ofthe pedicle nail 100. For example, depending upon the specificprocedure, the channel can allow the pedicle nail 100 to be maneuveredover and receive a Kirschner wire, commonly referred to as a K-wire. TheK-wire can typically be pre-positioned using imaging techniques, forexample, fluoroscopic imaging.

FIGS. 3A, 3B, and 3C illustrate an embodiment of a nail head 108. Asillustrated, the nail head 108 may have a proximal end 302 and a distalend 304. The proximal end 302 may comprise an insertion tool assemblyinterface 306 affixed therein. The distal end 304 may include mountingthreads 308 therein, wherein the mounting threads 308 may be designed tothreadably receive the mounting threads 216 affixed atop the proximalend 104 of the shank 102 (e.g., shown on FIG. 1C) of the pedicle nail100. The embodiment of the nail head 108 also illustrates the bonethreads 110 affixed to the exterior of the nail head 108. Asillustrated, the bone threads 110 may extend from the distal end 304.Moreover, the bone threads 110 may be disposed on the distal end 304,the proximal end 302, or a combination thereof. During installation, thebone threads 110 can engage cortical bone 1002 (e.g., see FIGS. 10A and10B), for example, to secure the nail head 108. Embodiments of the nailhead 108 also illustrates tulip threads 309 affixed to the exterior ofthe nail head 108, for example, to be threadingly received by thecorresponding threads (e.g., mounting threads 604 on FIG. 6B) on a tulip(e.g., polyaxial tulip 600 shown on FIGS. 6A, 6B, and 6C). Asillustrated, the tulip threads 309 may extend from the proximal end 302and may be spaced apart from the bone threads 110.

Specifically referring to FIG. 3A, the insertion tool assembly interface306 which may act as a tool engagement surface, for example, that may beengaged by a screw-driving tool or other device. The insertion toolassembly interface 306 may permit a physician to apply torsional oraxial forces to the nail head 108 to drive the pedicle nail 100 (e.g.,shown on FIGS. 1A, 1B, and 2 ) into the bone. In the illustratedembodiment, the insertion tool assembly interface 306 of the nail head108 may be a polygonal recess. For instance, the polygonal recess may bea hexagonal recess that receives a hexagonal tool, such as an Allenwrench, for example. Although not shown, the insertion tool assemblyinterface 306 may be configured to encompass tool engagement surfaceshaving other shapes, such as slot or cross. In an alternative embodiment(not illustrated), the insertion tool assembly interface 306 may beconfigured with a protruding engagement surface that may engage with atool or device having a corresponding recess.

FIGS. 4A and 4B illustrate embodiments of a pedicle nail 100 with atulip, such as a monoaxial tulip 500 or a polyaxial tulip, 600, affixedthereto. FIG. 4A illustrates a polyaxial tulip 600 for mounting onto theproximal end 302 of the nail head 108. For example, the polyaxial tulip600 may be threaded onto the tulip threads 309. FIG. 4B illustrates amonoaxial tulip 500, wherein the monoaxial tulip 500 may be configuredto be threadably affixed atop the proximal end 104 of the shank 102. Forexample, the monoaxial tulip 500 may be threaded onto the mountingthreads 116 at the proximal end 104 of the shank 102.

FIGS. 5A, 5B, and 5C illustrate an embodiment of a monoaxial tulip 500.A monoaxial tulip 500 may be used for connecting vertebrae to rods inspinal surgery, especially during procedures that require the pediclenail 100 to remain immobile. For example, the monoaxial tulip 500 may beused in procedures that may require excessive tension. The tulip 500 maycomprise a bottom portion or distal end 524 and sidewalls 520 thatextend upwardly from the bottom portion 524. As illustrated, thesidewalls 520 may be generally parallel, and may define a recess 522 inthe head 526. The sidewalls 520 may have features, such as slots,recesses, or detents 515, on an inner surface for engaging a lockingassembly 807 (e.g., see FIGS. 8A, 8B, 8C, and 8D). The locking assembly807 may comprise corresponding protrusions or slots 815 (e.g., see FIG.8B) that permit the locking assembly 807 to engage with and rotate withrespect to the head 526. The outer portion of the sidewalls 520 maycomprise slots 525, or other suitable features, for receiving aninstrument. The head 526 may be configured to include insertion toolassembly interface 502, wherein cortical bone threads 504 can bedisposed at or near the bottom portion 524. Referring specifically toFIG. 5C, the bottom portion 524 may be configured to include mountingthreads 506 disposed therein, wherein the mounting threads 506 may beconfigured to threadably receive and attach to the proximal end 104 ofthe pedicle nail 100 with threadable connection to the mounting threads216 of the fenestrated pedicle nail 100 (e.g., shown on FIG. 2 ). Inaccordance with the embodiments, the monoaxial tulip 500 may include aseat 528, wherein the seat 528 may be U- or wedge-shaped, for example,and may be positioned in the head 526 against which an insertion toolassembly 800 may be seated and engaged. Although not shown, after themonoaxial tulip 500 has been threadably attached to the pedicle nail100, a surgical rod may be inserted therein, wherein the surgical rodmay be designed specifically for the particular pedicle nail 100 use inthe procedure.

FIGS. 6A, 6B, and 6C illustrate an embodiment of a polyaxial tulip 600that can include a proximal end 601, a distal end 603, and sidewalls 620that extend upwardly from the distal end 603. A polyaxial tulip 600 mayalso be used for connecting vertebrae to rods during spinal surgery. Thepolyaxial tulip 600 may include a housing 631, which allows the tulip600 a range of motion along several different axes relative to thehousing 631. A ball joint (not shown) may allow a surgeon flexibilitywhen implanting pedicle nails 100. As illustrated, the sidewalls 620 maybe generally parallel, and may define a recess 622, wherein the recess622 may surround a bore 623, where the bore 623 may have mountingthreads 604 disposed therein. The bore 623 with corresponding mountingthreads 604 may be configured to receive the tulip threads 109affixedatop the proximal end 104 of the nail head 108 (e.g., shown on FIGS. 3A,3B, and 3C). The upper portion of the sidewalls 620 may have features,such as slots, recesses, or detents 615, on an inner surface forengaging the locking assembly 807. The locking assembly 807 can comprisecorresponding protrusions or slots 815 that permit the locking assembly807 to engage with and rotate with respect to the tulip 600. The outerportion of the sidewalls 620 may comprise slots 625, or other suitablefeatures, for receiving an instrument. The proximal end 601 may beconfigured to include an insertion tool assembly interface 602. Therecess 622 may also provide for placement of a surgical rod (not shown),may be inserted therein, wherein the surgical rod may be designedspecifically for the particular pedicle nail 100 use in the procedure.

FIG. 7 illustrates an embodiment of a curved surgical bone awl 700. Asillustrated, the curved awl 700 may have a proximal end 702 with ahandle 708 attached thereto, a distal end 704, and a shaft 706. Ingeneral, the surgical bone awl 700 may be provided for orthopedicapplications that include creating or enlarging holes in the corticalbone 1002. As illustrated, the curved surgical bone awl 700 may have ashaft 706 and a cutting tip 710 that may mechanically lock in place intoa recess 712 formed in the end of the shaft 706. As known in the art, arelease mechanism (not shown) may be provided to allow the surgeon toselectively disengage the cutting tip 710 from the shaft 706. Moreover,the surgical bone awl 700 may include a hole-retention sleeve (notshown) which may surround at least part of the shaft 706 and the tip 710and may be configured to surround the entire shaft 706 and tip 710. Thecurvature angle β of the curved surgical bone awl 700 may be designed toconform with the curvature angle θ of the pedicle nail 100 (e.g., shownon FIGS. 1A, 1B, and 2 ). For example, the surgical bone awl 700 mayhave any suitable curvature angle β.

FIGS. 8A, 8B, 8C and 8D illustrate an embodiment of an insertion toolassembly 800 that may be used for insertion of the monoaxial tulip 500.As illustrated, the insertion tool assembly 800 may comprise a proximalend 845 and a distal end 803, wherein the proximal end 845 of theinsertion tool assembly 800 may comprise a driver 804. The driver 804may comprise a proximal end 901 (see FIG. 9A) and a distal end 903 (seeFIG. 9A). The distal end 803 of the insertion tool assembly 800 maycomprise an insertion tool 802. The insertion tool 802 may comprise aproximal end 801 and a distal end 817, wherein the distal end 903 of thedriver 804 may be removably connected to the proximal end 801 of theinsertion tool 802. Referring to the exploded view of FIG. 8B, thedistal end of the insertion tool 817 may comprise a retractable lockingassembly 807. The retractable locking assembly 807 may be a threadedshaft locking assembly for the monoaxial tulip 500. More specifically,the retractable locking assembly 807 may be seated in the insertion toolassembly interface 502 of the monoaxial tulip 500. The retractable shaftlocking assembly 807 may include an inner shaft 809 and an outer shaft811. As depicted in FIG. 8C and the exploded view of FIG. 8D, theretractable shaft locking assembly 807 may be retracted to allow theouter shaft 811 to be threaded into the monoaxial tulip 500.

FIGS. 9A and 9B illustrate an embodiment of a driver 804 coupled with apedicle nail 100. As illustrated, the pedicle nail 100 may comprise ashank 102 and a nail head 108. As depicted, the distal end 903 of thedriver 804 may be coupled to the insertion tool assembly interface 306of the nail head 108. Referring to the exploded view of FIG. 9B, thedriver 804 may be directly coupled to the insertion tool assemblyinterface 306, wherein the interface 306 may be positioned within theproximal end 104 of the nail head 108, wherein the nail head 108 may bethreadably connected to the mounting threads 216 positioned at theproximal end 104 of the pedicle nail 100.

FIGS. 10A and 10B illustrate an embodiment of a curved awl 700 creatinga pathway for insertion of a pedicle nail 100. As illustrated, thecurved awl 700 may create a pathway for insertion of the pedicle nail100 into a cortical bone 1002, wherein the pathway may be created bymaneuvering the cutting tip 704. As known in the art, a releasemechanism (not shown) may be provided to allow the surgeon toselectively disengage the cutting tip 710 from the shaft 706. Moreover,the curved awl 700 may include a hole-retention sleeve (not shown) whichmay surround at least part of the shaft 706 and the tip 710 and may beconfigured to surround the entire shaft 706 and tip 710. The curvatureangle β of the curved surgical bone awl 700 may be designed to conformwith the curvature angle θ of the pedicle nail.

FIGS. 11A and 11B illustrate an embodiment of a pedicle nail 100,including a driver 804, with a tamping device 1102 driving the pediclenail 100 into a cortical bone 1002. As depicted, the pedicle nail 100may comprise a shank 102 with a nail head 108. The driver 804 may becoupled to the nail head 108 at the insertion tool interface 306. Asfurther illustrated in FIG. 11B, the pedicle nail 100 and the driver 804may be tamped down with a tamping device 1102 up to and until the nailhead 108 contacts the cortical bone 1002.

FIGS. 12A and 12B illustrate a polyaxial tulip insertion procedure withan embodiment of the nail head 108 of a pedicle nail 100 being threadedinto a cortical bone 1002 with an insertion tool assembly. Asillustrated, the nail head 108 may be threaded into the cortical bone1002. After the nail head 108 has been secured into the cortical bone1002, a polyaxial tulip 600 may be threadably connected to the tulipthreads 109 positioned at the proximal end 302 of the nail head 108.

FIGS. 13A, 13B, and 13C illustrate a monoaxial tulip insertion procedurewith an embodiment of the pedicle 100. As illustrated on FIG. 13A, thenail head 108 (not shown) may be removed from the pedicle nail 100 aftertamping of the pedicle nail 100 into the cortical bone 1002. Asillustrated on FIG. 13B, monoaxial tulip 500 may be attached to pediclenail 100. In the illustrated embodiment, the insertion tool assembly 800may be used to attach the monoaxial tulip 500 to the pedicle nail 100.By clockwise rotation of the insertion tool assembly 800, the bonethreads 504 of the monoaxial tulip 500 may be threadably secured to thecortical bone 1002. After the pedicle nail 100 and monoaxial tulip 500have been secured in the desired location, the insertion tool assembly800 may be withdrawn, as shown on FIG. 13C, and the surgical rods (notshown) may then be implanted.

FIGS. 14A and 14B illustrate the final placement of tulips in relationto the cortical bon 1002. As illustrated on FIG. 14A, the polyaxialtulip 600 may be positioned on the cortical bone 1002 with the pediclenail 100 (not shown) disposed in the cortical bone 1002. As illustratedon FIG. 14B, the monoaxial tulip 600 may be positioned on the corticalbone 1002 with the pedicle nail 100 (not shown) disposed in the corticalbone 1002.

The invention being thus described, it will be obvious that the same maybe varied in many ways. Such variations are not to be regarded as adeparture from the spirit and scope of the invention, and all suchmodifications as would be obvious to one skilled in the art are intendedto be included within the scope of the following claims.

What is claimed is:
 1. A pedicle nail system comprising: a pedicle nailhaving a shank including a proximal end and a distal bone engagementend, the pedicle nail further including a nail head disposable on theproximal end of the shank, wherein the nail head threadably engages theproximal end, the nail head having external bone threads; and a tulip,wherein the tulip comprises a proximal end and a distal end.
 2. Thepedicle nail of claim 1, wherein the shank is a curved shank, having acurvature angle θ.
 3. The pedicle nail of claim 2, wherein the shankcomprises fenestrated perforations about the longitudinal axis thereof,wherein the number of fenestrated perforations can range from about 2 toabout
 100. 4. The pedicle nail of claim 3, wherein the shank comprisesat least two protrusions configured along the longitudinal axis thereof,wherein the protrusions form channels along the longitudinal axis,wherein the protrusions have an exposed vertical edge, wherein thevertical edge has at least two notches, wherein the notches are invertical alignment with one another.
 5. The pedicle nail of claim 1,wherein the proximal end comprises mounting threads, wherein themounting threads have a pitch, wherein the bone threads have a pitch,and wherein the pitch of the mounting threads and the pitch of the bonethreads are unequal.
 6. The pedicle nail of claim 5, wherein the pitchof the bone threads is greater than the pitch of the mounting threads.7. The pedicle nail of claim 1, wherein the nail head comprises externalbone threads thereabout, wherein the nail head has a proximal end and adistal end, wherein the distal end of the nail head threadably engageswith the proximal end of the shank, and wherein the proximal end of thenail head comprises an insertion assembly tool interface therein.
 8. Thepedicle nail system of claim 1, wherein the tulip is a monoaxial tulip,wherein the monoaxial tulip comprises external bone threads disposed onor about the distal end thereof, wherein the monoaxial tulip isconfigured to be disposed on the proximal end of the shank by threadablyreceiving the mounting threads attached thereto.
 9. The pedicle nailsystem of claim 8, further comprising a nail head having a proximal endand a distal end; wherein the nail head comprises external bone threads;and wherein the distal end of the nail head is configured to be disposedon the proximal end of the shank by threadably receiving the mountingthreads attached thereto.
 10. The pedicle nail system of claim 9,wherein the proximal end of the nail head comprises an insertionassembly tool interface therein.
 11. A pedicle nail system comprising: apedicle nail, wherein the pedicle nail comprises a shank, wherein theshank comprises a proximal end and a distal bone engagement end, whereinthe proximal end comprises mounting threads attached thereto; and atulip wherein the tulip comprises a proximal end and a distal end,wherein the distal end of the tulip is configured to be mounted on thepedicle nail; and a driver, wherein the driver comprises a proximal endand a distal end; wherein the distal end of the driver is removablyconnected to the proximal end of the insertion tool assembly.
 12. Thepedicle nail of claim 1, wherein the shank is a curved shank, having acurvature angle θ.
 13. The pedicle nail of claim 12, wherein the shankcomprises fenestrated perforations about the longitudinal axis thereof,wherein the number of fenestrated perforations can range from about 2 toabout
 100. 14. The pedicle nail of claim 13, wherein the shank comprisesat least two protrusions configured along the longitudinal axis thereof,wherein the protrusions form channels along the longitudinal axis,wherein the protrusions have an exposed vertical edge, wherein thevertical edge has at least two notches, wherein the notches are invertical alignment with one another.
 15. The pedicle nail of claim 11,wherein the proximal end comprises mounting threads, wherein themounting threads have a pitch, wherein the bone threads have a pitch,and wherein the pitch of the mounting threads and the pitch of the bonethreads are unequal.
 16. The pedicle nail of claim 15, wherein the pitchof the bone threads is greater than the pitch of the mounting threads.17. The pedicle nail of claim 11, wherein the nail head comprisesexternal bone threads thereabout, wherein the nail head has a proximalend and a distal end, wherein the distal end of the nail head threadablyengages with the proximal end of the shank, and wherein the proximal endof the nail head comprises an insertion assembly tool interface therein.18. The pedicle nail system of claim 11, wherein the tulip is amonoaxial tulip, wherein the monoaxial tulip comprises external bonethreads disposed on or about the distal end thereof, wherein themonoaxial tulip is configured to be disposed on the proximal end of theshank by threadably receiving the mounting threads attached thereto. 19.The pedicle nail system of claim 18, further comprising a nail headhaving a proximal end and a distal end; wherein the nail head comprisesexternal bone threads; and wherein the distal end of the nail head isconfigured to be disposed on the proximal end of the shank by threadablyreceiving the mounting threads attached thereto.
 20. The pedicle nailsystem of claim 19, wherein the proximal end of the nail head comprisesan insertion assembly tool interface therein.